Kornimate/medical-research-clean huggingface dataset:
comparing efficacy and safety between eperisone a bid and a tid regimen in acute low back pain patients

Conditions: Low Back Pain

Summary: multi-center study to compare efficacy and safety between eperisone a bid and a tid regimen in acute low back pain patients during 7 days.


Eligibility criteria:
inclusion criteria: * subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing * 20≤ age ≤60 * a patient has symptom of acute low back pain * 4≤ vas exclusion criteria: * subjects who cannot prohibit anti-inflammatory drug, painkiller or muscle relaxants during clinical trial * chronic rheumatoid arthritis patients * patients having a medical history of hypersensitivity to eperisone hydrochloride * subject having a hereditary problem such as galactose intolerance, lapp lactase deficiency, or glucose galatose malabsorption * participation in other studies before 60 days of first dosing * female patients having positive pregnancy test, lactating women,planning pregnancy during clinical trial * inadequate subject for the clinical trial by the investigator's decision
repeated assessment of survivors in intracerebral hemorrhage study

Conditions: Intra Cerebral Hemorrhage; ICH - Intracerebral Hemorrhage; ICH; Hemorrhage; Stroke; Clot (Blood); Brain; Clot Blood; Cognitive Decline; Cognitive Impairment; Survivorship; Memory Impairment; Motor Activity

Summary: the investigators propose to perform serial detailed cognitive, motor, behavioral, and blood collection follow-up using longitudinal structured telephone interviews of an anticipated 350 ich survivors enrolled in minimally invasive surgery plus alteplase for intracerebral hemorrhage evacuation (mistie) iii and enrich trials to identify specific cognitive and motor impairment and to perform rna sequencing to evaluate for evidence of chronic inflammation. the investigators' expected sample size in 2022 accounts for mortality attrition of 10%/year.

the reassess study will conduct long-term cognitive, functional, and neuropsychiatric performance assessments to determine if evacuation of spontaneous intracerebral hemorrhage (ich) reduces the risk of later cognitive decline in the ageing brain. this study will compare rates of cognitive decline under two treatment strategies for intracerebral hemorrhage: the use of minimally invasive surgery with two similar techniques as performed in the mistie iii and enrich trials, and the current standard of care using data from controls in mistie iii and enrich and comparative data from the ethnic/racial variations of ich (erich) study (u-01-ns067963) extended into the erich-longitudinal study (r01-ns093870) which followed over 900 of erich cases with serial cognitive examinations.

Eligibility criteria:
inclusion criteria: * participants in the study must be survivors enrolled in mistie iii and enrich trials at end of each trial's final follow-up (day 365 in mistie iii and day 180 in enrich). relatives of known survivors that are found to be deceased since the end of each trial will be interviewed to capture relevant data. exclusion criteria: * none

Keywords: intracerebral hemorrhage stroke cognitive impairment
effect of watermelon on gut and cardiometabolic health

Conditions: Obesity and Overweight; Dysbiosis

Summary: the goal of this clinical trial is to evaluate the effect of daily fresh watermelon consumption for 6-weeks on gut health, including microbiome diversity, gut barrier and immune function in young adults with overweight and obesity. the main questions it aims to answer are: 1. will consuming fresh watermelon daily for 6-weeks will improve intestinal barrier health and increase microbiome diversity such as an increased population of beneficial 'probiotic' bacteria when compared to control participants consuming a low-fat snack? 2. will consuming fresh watermelon daily for six-weeks will improve other health measures, including body-composition, blood pressure, blood vessel function, blood lipid profiles, and measures of inflammation, as compared to control participants consuming a low-fat snack for the same time period?


Eligibility criteria:
inclusion criteria: * between 18 and 30 years old * ability to speak and read in english * overweight or obese class 1 and 2 (bmi ≥ 25 - 39.9 kg/m2) exclusion criteria: * intake of antibiotics in the last 3 months * intake of pre/pro/postbiotics in the last 3 months * current or past (within the last 6 months) user of tobacco, marijuana, or e-cigarette products * cardiovascular disease (will not exclude for hypertension), gastrointestinal disease (ulcerative colitis, celiac, crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - a1c greater than 9%). * food allergy to study foods * any allergy to melon * any allergy to the isocaloric snack (gluten) * regular consumption of watermelon greater than 2 servings / week * current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women * class 3 obesity (bmi \&amp;gt; 40 kg/m2) * current user of citrulline, arginine, nitric oxide or other supplements known to affect nitric oxide synthesis (beet root juice or any beet supplement, pycnogenol / pine bark extract) * known to be currently pregnant (self-disclosed)

Keywords: gut microbiome dysbiosis diet overweight obesity watermelon lycopene citrulline metagenomic vascular
innovative rehabilitation: integrating vr-based sensorimotor training into comprehensive neck rehabilitation

Conditions: Chronic Non Specific Neck Pain

Summary: the research aims to treat chronic non-specific neck pain using virtual reality (vr) technologies with sensory-motor training. chronic neck pain is widespread and highly prevalent in egyptian society due to many factors, such as sitting for long periods in front of a computer or smartphone, which leads to a decline in productivity at work and a constant feeling of fatigue. this problem is considered one of the widespread health problems that affect individuals of all ages and greatly affect their daily lives. this project was chosen based on the growing awareness of the need to search for innovative solutions to this health problem that hinders productivity and affects the general comfort of individuals. the reserch aims to integrate sensory-motor therapy with virtual reality, which helps patients improve movement and flexibility and reduce pain. it does this by simulating exciting interactive environments that engage their attention and help them relieve pain away from traditional treatment methods.

virtual reality, a novel form of technology, is gaining attention in the medical field for its potential to aid inpatient rehabilitation. this experience will immerse the patient in an interactive and engaging journey. virtual reality feedback can assist patients with chronic musculoskeletal pain by offering them various sensory and motor tasks to enhance their postural control. moreover, virtual reality offers a distracting experience that aids in reducing patients' pain and emotional distress. using a specialized device on their head (head-mounted device) (hmd) or screen, patients can participate in computer-based exercises as part of virtual reality physical therapy. combining virtual reality with comprehensive sensorimotor training can be beneficial in treating chronic neck pain.

Eligibility criteria:
inclusion criteria: 1. fifty patients diagnosed with mechanical neck pain between 18- and 40 years old with mechanical neck pain. 2. patients with pain intensity scores (\>3) on the visual analog scale (vas; 0-100mm) for an average of three weeks before the study. 3. neck disability index (ndi) scoring 20%-60% (\>6) (moderate to severe disability). exclusion criteria: 1. any history of lower extremity or spine trauma or surgery, recognized and observable spinal deformity, neurological disorders, cervical fracture/dislocation, whiplash injuries, neurological/cardiovascular/respiratory disorders affecting patients' physical performance, or inability to provide informed consent. 2. benign paroxysmal positional vertigo (bppv), as confirmed by the dix hallpike test. 3. pregnancy. 4. patients who had received physical therapy interventions for neck pain within three months preceding the study were also ineligible for participation and were excluded.

Keywords: virtual reality (vr) non specific neck pain (nsnp) neck-based training sensorimotor training sensorimotor training
skolkontakt - social skills training in a school setting

Conditions: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Anxiety; Depression

Summary: the study investigates the behavioral effects of an adapted manual-based social skills training program (skolkontakt) for the mainstream education plan delivered by school personnel, with pupils (15-20 years) with social-communication needs; either formally diagnosed (i.e. autism spectrum disorders or adhd) or teacher-reported subclinical difficulties. n=40 are recruited from a community school in the stockholm area (sweden).

so far, research has failed to consider the effectiveness of social skills training in school settings, and has instead focused on clinical or laboratory settings. this approach presents an interesting paradox given that the primary goal of social skills training is to affect change in the child's behavior in everyday life including school. research undertaken in authentic everyday environments is not only more likely to result in real world outcomes for children and adolescents with asd and adhd, but greater utility in guiding models of service delivery. the objective of the current line of research is to adapt and evaluate methods originally designed to support children and adolescents with asd and adhd in clinical settings ("kontakt"), to be feasible and effective in school settings, that can be conducted by school personnel, and are are applicable to children with autistic and inattentive, hyperactive-impulsive disorders, as well as other less defined special social needs ("skolkontakt").

Eligibility criteria:
inclusion criteria: * formally diagnosed autism spectrum disorder * formally diagnosed attention deficit hyperactivity disorder * teacher-reported subclinical social-communication special needs exclusion criteria: * severe psychiatric comorbidity that challenges administration of the group-intervention, including but not limited to severe oppositional defiant disorder * severe psychiatric comorbidity that makes the participant to vulnerable to participate in the group-intervention, including but not limited to suicidality, severe depression

Keywords: social skills group training school-based intervention evidenced-based intervention
inpwt on wound complications & clinical outcomes after lower extremity sarcoma surgery preop radiation therapy patients

Conditions: Soft-tissue Sarcoma; Wound Complication

Summary: project summary - aggressive soft tissue cancers are commonly treated with radiation followed by surgery. these wounds have a very high rate of wound complications and infection (30%), resulting in more surgeries, longer hospital stays and complex nursing care. previous research shows that negative pressure (vacuum) dressings applied to the incision at the end of surgery can reduce these complications. the investigator and his team across canada will perform a clinical trial comparing standard dressings to these vacuum dressings. the results of this study have the potential to immediately improve the quality of life of soft tissue cancer patients. it can also decrease the amount of time required in hospital and reduce the cost to the canadian healthcare system.

this is a multi-center randomized clinical trial lead by the investigator from the ottawa hospital and six other orthopedic cancer centers. the investigator and the team will be recruiting 248 patients diagnosed with soft tissue cancer who will be treated with radiation therapy followed by surgery. each of these patients will be randomly assigned to receiving either 7 days of vacuum dressing (incisional negative pressure wound therapy) or a standard dressing. besides this, patients will receive as identical care as possible. the team will then closely follow these patients over a period of 4 month to examine differences in wound complications, length of hospital stay, patient quality of life, patient satisfaction and function. statistical analysis will be completed by the ottawa methods center and ethical approval will be obtained at each participating site.

Eligibility criteria:
inclusion criteria: * patients 18 years of age and older and are able to provide written consent. * patients with lower extremity soft tissue sarcoma confirmed by tissue pathology.each patient must have local cross sectional imaging (ct or mri) and a staging ct chest. * patients eligible for treatment with preoperative radiation therapy followed by limb salvage surgery. * patients for which a primary closure must be attained at the time of surgery. * patient must be available for postoperative follow-up at the treating center. exclusion criteria: * patients who are less than 18 years of age. * patients with a benign disease or with prior radiation to the anatomic region in the remote past (not associated with current treatment radiation plans). * patients who underwent surgical amputation * patients in which primary closure was not achieved (including free flaps and split thickness skin grafts). * patients with a life expectancy less than 120 days. * patients who have an allergy or sensitivity to adhesive dressings.

Keywords: sarcoma wound therapy
an extension study to evaluate the efficacy and safety of bmn 111 in children with achondroplasia

Conditions: Achondroplasia

Summary: the intent and design of this phase 3 study is to assess bmn 111 as a therapeutic option for the treatment of children with achondroplasia


Eligibility criteria:
inclusion criteria: * must have completed study 111-301 * female \>= 10 years old or who have begun menses must have a negative pregnancy test at the baseline visit and be willing to have additional pregnancy tests during the study * if sexually active, willing to use a highly effective method of contraception while participating in the study * are willing and able to perform all study procedures * parent(s) or guardian(s) are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to performance of any research-related procedure. also, subjects under the age of majority are willing and able to provide written assent (if required by local regulations or the irb/iec) after the nature of the study has been explained and prior to performance of any research-related procedure. subjects who reach the age of majority in their country while the study is ongoing will be asked to provide their own written consent again upon reaching the legal age of majority. exclusion criteria: * permanently discontinued bmn 111 or placebo prior to completion of the 111-301 study * have a clinically significant finding or arrhythmia on baseline ecg that indicates abnormal cardiac function * evidence of decreased growth velocity (\<1.5 cm/year) as assessed over a period of at least 6 months or of growth plate closure (proximal tibia, distal femur) through bilateral lower extremity x-rays. * require any investigational agent prior to completion of study period * current therapy with medications known to alter renal function * pregnant or breastfeeding or plan to become pregnant during study * concurrent disease or condition that, in the view of the investigator, would interfere with study participation or safety evaluations, for any reason. * have a condition or circumstance that, in the view of the investigator, places the subject at high risk for poor treatment compliance or for not completing the study.

Keywords: ach achondroplasia bone diseases bone diseases, developmental dwarfism genetic diseases, inborn musculoskeletal diseases natriuretic agents natriuretic peptide, c-type osteochondrodysplasias physiological effects of drugs skeletal dysplasias
personalized dietary intervention in managing bowel dysfunction and improving quality of life in stage i-iii rectosigmoid cancer survivors

Conditions: Cancer Survivor; Stage I Rectosigmoid Cancer; Stage II Rectosigmoid Cancer; Stage III Rectosigmoid Cancer

Summary: this pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage i-iii rectosigmoid cancer survivors. personalized dietary intervention may help people understand bowel symptoms, identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation based on food triggers, and coach on healthy diet recommendations after cancer treatment.

primary objectives: i. administer and determine the feasibility of the personalized dietary intervention. ii. using qualitative methods, evaluate the acceptability of the intervention as reported by survivors. iii. explore decisional conflict associated with treatment decision-making in rectal cancer surgery. outline: at 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. patients also receive a workbook including reference materials and intervention content. after completion of study, patients are followed up for 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis of stage i-iii cancers of the rectosigmoid colon or rectum * 6 months post-treatment completion * have a permanent ostomy or anastomosis * english-speaking * all subjects must have the ability to understand and the willingness to sign a written informed consent exclusion criteria: * patients with stage iv disease will be excluded from the study * subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
study of the role of innate lymphoid cells and natural killer cells in immune activation of vitiligo - innate vitiligo

Conditions: Vitiligo

Summary: the cohort included only major patients with non-segmental vitiligo and no other autoimmune or inflammatory associated diseases (except thyroiditis). control subjects should have no autoimmune or inflammatory diseases. patients and controls should not take treatment with corticosteroids or other potentially immunomodulatory therapies. patients and controls are recruited in the dermatology department of the university hospital of nice and the hospital of fréjus. the investigators have already initiated the collection of tissues and blood from patients and control subjects and we have succeeded in isolating ilcs and nks from a blood volume of 50ml. we were able to sort the ilc subpopulations. early data suggest an increase in natural killer (nk) and innate lymphoïdes cells 1 (ilc1) in the blood of vitiligo patients compared to control subjects. the investigators also managed to extract the melanocytes from the skin biopsies of the first patients and control subjects.

the investigators want study the presence and type of ilc and nk in the blood and skin of vitiligo patients compared to control subjects.

Eligibility criteria:
inclusion criteria: vitiligo subjects : * patients in the cohort with non-segmental vitiligo * without other autoimmune or inflammatory diseases associated control subjects : * subject without autoimmune or inflammatory disease
probiotic lactobacillus reuteri to prevent antibiotic-associated diarrhea and clostridium difficile-related infections in hospitalized children

Conditions: Antibiotic Associated Diarrhea; Clostridium Difficile Infection; Gastroenteritis

Summary: the purpose of this study is to determine if the daily intake of the probiotic lactobacillus reuteri prevents antibiotic-associated diarrhoea and related clostridium difficile infections in children and adolescents.

antibiotic-associated diarrhoea (aad) occurs in up to 25% of all individuals receiving antibiotics (bartlett, 2002). in hospitalized patients, aad is related to significant increases in mortality, length of stay, and cost of medical care (mcfarland, 2006). twenty-nine percent of hospitalized patients may develop diarrhoea after antibiotic use; therefore, identifying strategies to minimize antibiotic-associated diarrhoea could be of significant medical and economic advantage (mcfarland, 1998). a promising tool in this area is the probiotic lactobacillus reuteri

Eligibility criteria:
inclusion criteria: * 3 - 18 years of age * receiving antibiotics for not more than 48 hours prior to enrolment and free from diarrhoea * the signed informed consent by one/both parents / legal guardian and by the subject if she/he is 12 years or older * available throughout the study period * no use of any other probiotic products during the study period (bulgarian yoghurt without added probiotics can be used) * subject or parents/guardian should have the mental ability to understand and willingness to fulfil all the details of the protocol exclusion criteria: * three or more soft and unformed or watery stools per day at admission * receiving chemotherapy or radiation therapy * diagnosis of inflammatory bowel disease * enteral or parenteral nutrition only * requiring care in an intensive care unit * status post-bowel resection during hospitalization * receiving antibiotics four weeks prior to hospitalization * patient with severe life threatening illness or immunocompromised (hiv/aids, cancer, genetic disorders including cystic fibrosis, children with opportunistic infections, metabolic diseases) * pregnancy * lack of possibility to store the study product in a temperature below 25°c during the hot season of the year

Keywords: probiotic aad lactobacillus reuteri diarrhea
diathermy vs scalpel in abdominal incision in women undergoing cs

Conditions: Incision, Surgical

Summary: cesarean section is surging worldwide. for an extended period of surgical practice, the scalpel has been well-known as a gold-standard tool for making surgical incisions. the diathermy, electrocautery, is a substitute.


Eligibility criteria:
inclusion criteria: * women with bmi 30- 40 kg/m2. * women pregnant with singletons and planned to have a repeat elective lower-segment cs at 38-39 weeks' gestation due to having had one previous cs. * women pregnant with singletons and planned to deliver by lower-segment cs at 38-39 weeks' gestation for the first time (primi-section) due to obstetric indication. exclusion criteria: * cases with coagulopathies eg. hemophilia, von willebrand disease * cases on anti-coagulant therapy eg. heparin, warfarin * cases with chronic diseases expected to affect wound healing, such as diabetes, hypertension, liver diseases, chronic anemia, and renal impairment.

Keywords: diathermy scalpel cesarean section obese